NCT04440189

Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis

Use of GID SVF-2 Device to Produce Autologous Adipose-Derived Stromal Vascular Fraction for Treatment of Osteoarthritis of the Knee: A Pivotal Medical Device Randomized Concurrent Controlled Study

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: GID BIO, Inc. · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.

Detailed description

This is a prospective, randomized, placebo controlled, parallel groups, double blind, multi-center, interventional study of subjects with osteoarthritis of the knee. Subjects will be randomized to receive an injection of LR (placebo) or SVF derived from their own adipose tissue (experimental).

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	GID SVF-2 Device System	The GID SVF-2 Device System is used for harvesting, filtering, separating and concentrating autologous stromal vascular fraction from adipose tissue.

Timeline

• Start date: 2020-10-15
• Primary completion: 2024-12-30
• Completion: 2025-06-30
• First posted: 2020-06-19
• Last updated: 2025-04-23

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study